厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.166456364413643046448164423644370.15
210.116483464984649090.17
单位质量响应值RSD%判断
6342.226420.280.87数据可信
供试品溶液-BJ86589批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min115395-1539521.69614.5530.2421.7014.5530.26
212278-1227817.30317.30
36460-64609.1049.10
410064-1006414.18314.18
59096-909612.81912.82
68674-867412.22412.22
10min126300-2630037.06530.3615.5837.3130.5215.65
225155-2515535.45135.64
318262-1826225.73725.84
420395-2039528.74328.90
520191-2019128.45528.60
618948-1894826.70426.84
15min132661-3266146.02939.7812.2646.6840.2812.35
231692-3169244.66445.25
324370-2437034.34534.73
429067-2906740.96441.44
526331-2633137.10837.57
625229-2522935.55535.99
20min136691-3669151.70945.5710.7652.8746.5110.86
236065-3606550.82751.91
328665-2866540.39841.17
433073-3307346.61047.54
530058-3005842.36143.23
629448-2944841.50142.33
30min142390-4239059.74055.118.1361.4856.568.28
243078-4307860.71062.36
335451-3545149.96151.18
439903-3990356.23657.69
537252-3725252.49953.84
636562-3656251.52752.82
45min150505-5050571.17765.856.6973.5867.916.85
250117-5011770.63072.95
343497-4349761.30163.07
447631-4763167.12769.20
544350-4435062.50364.43
644266-4426662.38464.25
60min155112-5511277.67072.936.4080.8675.726.55
255665-5566578.44981.56
347784-4778467.34269.80
453032-5303274.73877.56
549333-4933369.52572.14
649550-4955069.83172.39
90min161828-6182887.13582.415.1791.1986.015.36
262178-6217887.62891.61
355488-5548878.20081.40
458996-5899683.14386.79
555511-5551178.23281.62
656834-5683480.09783.43
120min163777-6377789.88188.403.3694.9192.923.56
265830-6583092.77597.73
361659-6165986.89690.97
463565-6356589.58394.16
559794-5979484.26888.53
661723-6172386.98791.21
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限164256-6425690.55691.241.2096.5896.741.29
265626-6562692.48798.47
364210-6421090.49295.53
464593-6459391.03196.60
563967-6396790.14995.35
665784-6578492.71097.90
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.166507365161650786508365146651080.07
210.116558165763656720.20
单位质量响应值RSD%判断
6408.276495.750.96数据可信
供试品溶液-BJ86589批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min121404-2140429.83423.7417.5629.8323.7417.56
217666-1766624.62424.62
318849-1884926.27326.27
415844-1584422.08422.08
515761-1576121.96921.97
612687-1268717.68417.68
10min143128-4312860.11555.788.0460.4556.048.08
240601-4060156.59256.87
344060-4406061.41461.71
438609-3860953.81654.06
538152-3815253.17953.42
635561-3556149.56749.76
15min152513-5251373.19671.691.6874.2072.571.70
250185-5018569.95170.85
351932-5193272.38673.36
450857-5085770.88871.73
551119-5111971.25372.09
651986-5198672.46173.21
20min157988-5798880.82779.852.1482.6481.542.04
256533-5653378.79980.48
355966-5596678.00979.79
456860-5686079.25580.89
557005-5700579.45781.08
659384-5938482.77384.33
30min162635-6263587.30587.962.6390.0290.532.50
261807-6180786.15088.71
361815-6181586.16288.81
463257-6325788.17290.68
562823-6282387.56790.08
666281-6628192.38794.86
45min165747-6574791.64292.521.8795.3296.061.78
264871-6487190.42193.93
366129-6612992.17595.78
465964-6596491.94595.44
568446-6844695.40498.89
667097-6709793.52497.02
60min165842-6584291.77592.470.5996.4797.040.53
265861-6586191.80196.32
366518-6651892.71797.34
466641-6664192.88897.40
566494-6649492.68497.23
666696-6669692.96597.50
90min164722-6472290.21490.901.1195.9396.501.04
264398-6439889.76295.30
365411-6541191.17496.83
464693-6469390.17395.72
566138-6613892.18797.76
665936-6593691.90697.48
120min164860-6486090.40691.280.8597.1397.890.80
264911-6491190.47797.01
366139-6613992.18998.86
465295-6529591.01297.56
565660-6566091.52198.12
666044-6604492.05698.65
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限163692-6369288.77888.220.9096.5095.840.84
263610-6361088.66496.20
362668-6266887.35195.05
462481-6248187.09094.65
563808-6380888.94096.55
663480-6348088.48296.10
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.166457564696645956458264694646280.10
210.116451964591645550.08
单位质量响应值RSD%判断
6361.026385.260.27数据可信
供试品溶液-BJ86589批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114258-1425820.11920.2213.4820.1220.2213.48
217337-1733724.46324.46
313667-1366719.28519.28
411376-1137616.05216.05
514359-1435920.26120.26
614983-1498321.14221.14
10min128550-2855040.28642.588.1840.5142.808.20
232877-3287746.39146.66
331952-3195245.08645.30
426111-2611136.84437.02
531010-3101043.75743.98
630552-3055243.11043.35
15min136999-3699952.20754.355.3952.8855.055.43
240269-4026956.82257.61
340287-4028756.84757.56
435100-3510049.52850.12
538828-3882854.78855.50
639619-3961955.90456.62
20min143001-4300160.67762.634.1461.9363.934.20
245668-4566864.44065.86
346449-4644965.54266.89
441526-4152658.59559.73
544356-4435662.58963.91
645311-4531163.93665.27
30min150480-5048071.23073.713.3673.1675.713.42
254254-5425476.55578.69
353748-5374875.84177.92
449951-4995170.48372.27
551994-5199473.36675.38
653005-5300574.79376.84
45min155994-5599479.01081.543.2481.7384.353.28
257888-5788881.68384.67
359638-5963884.15287.07
455052-5505277.68180.25
558906-5890683.11985.95
659231-5923183.57886.45
60min158923-5892383.14385.142.6586.7488.862.68
260128-6012884.84488.74
360755-6075585.72889.58
458493-5849382.53785.97
560749-6074985.72089.47
662971-6297188.85592.66
90min161023-6102386.10786.771.9290.6391.441.91
262502-6250288.19493.03
359996-5999684.65789.46
460592-6059285.49889.85
563089-6308989.02293.73
661748-6174887.13091.92
120min161183-6118386.33287.812.3991.8193.452.35
261754-6175487.13892.95
361920-6192087.37293.12
461454-6145486.71592.02
561875-6187587.30993.00
665210-6521092.01597.78
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限162171-6217187.72687.711.4094.1694.321.42
261401-6140186.64093.42
362677-6267788.44095.16
461436-6143686.68992.96
561638-6163886.97493.64
663625-6362589.77896.56
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